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Prostaglandin Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Priapism (8417294-8)
on May 28, 2012 Male from UNITED STATES , 55 years of age, was diagnosed with
  • erectile dysfunction
and was treated with Prostaglandin E1. Directly after, patient experienced the unwanted or unexpected Prostaglandin side effects: priapism. Prostaglandin E1 dosage: 1 Df, Unk.
Associated medications used:
  • Papaverine
  • Cialis (5 Mg, Qd)
  • Phentolamine Mesylate


Visual Impairment (7920223-4)
Patient was taking Prostaglandin. Patient felt the following Prostaglandin side effects: visual impairment on Nov 16, 2011 from JAPAN Additional patient health information: Male , 50 years of age, . Prostaglandin dosage: Unk.
Multiple prescriptions taken:
  • Sanpilo (Unk)
  • Varenicline Tartrate (Unk)


Extremity Necrosis, Condition Aggravated, Raynaud's Phenomenon, Prothrombin Time Prolonged, Ischaemia, Gangrene, Multi-organ Failure (7738105-X)
Adverse event was reported on Aug 25, 2011 by a Male taking Prostaglandins(prostaglandins) (Dosage: N/A) . Location: JAPAN , 69 years of age, After Prostaglandin was administered, patient encountered several Prostaglandin side effects: extremity necrosis, condition aggravated, raynaud's phenomenon, prothrombin time prolonged, ischaemia, gangrene, multi-organ failure.
Multiple concurrent drugs taken:
  • Gemcitabine (400.00-mg/m2, 80.00-mg-1.0days)
  • Gemcitabine (400.00-mg/m2, 80.00-mg-1.0days)
Patient was hospitalized.

Neonatal Asphyxia, Caesarean Section (7571395-5)
on Jun 21, 2011 Female from JAPAN , weighting 6.77 lb, was diagnosed with
  • labour induction
  • premature rupture of membranes
  • infection prophylaxis
and was treated with Prostaglandin F2 Alpha. Directly after, patient experienced the unwanted or unexpected Prostaglandin side effects: neonatal asphyxia, caesarean section. Prostaglandin F2 Alpha dosage: 3 Mg, 1x/day.
Associated medications used:
  • Cefaclor (250 Mg, 1x/day)
  • Unasyn (1.5 Mg, 1x/day)



Renal Disorder, Escherichia Infection, Renal Failure Acute, Fibroma, Septic Shock, Transplant Rejection, Thrombosis (7537048-4)
on May 26, 2011 Female from FRANCE , 34 years of age, was treated with Prostaglandins. Patient felt the following Prostaglandin side effects: renal disorder, escherichia infection, renal failure acute, fibroma, septic shock, transplant rejection, thrombosis. Prostaglandins dosage: N/A.
Multiple prescriptions taken:
  • Mifepristone (mifeprex)
  • Methergine (Unk)
  • Cytotec
Patient was hospitalized.

Renal Failure Acute, Multi-organ Failure, Lymphocyte Count Increased, Pulmonary Oedema, Pyrexia, Cytokine Release Syndrome, Hypoxia, Shock (7376563-3)
Patient was taking Prostaglandin E1. After Prostaglandin was administered, patient encountered several Prostaglandin side effects: renal failure acute, multi-organ failure, lymphocyte count increased, pulmonary oedema, pyrexia, cytokine release syndrome, hypoxia, shock on Mar 17, 2011 from KOREA, REPUBLIC OF Additional patient health information: Female , weighting 35.27 lb, was diagnosed with
  • prophylaxis
and. Prostaglandin E1 dosage: 10 Mcg, Unk.
Multiple concurrent drugs taken:
  • Acetaminophen (Unk)
  • Thymoglobulin (37.5 Mg, Qd)
  • Fludara
  • Corticosteroids (Unk)
  • Sol Medrol (15 Mg, Qd)
  • Thymoglobulin (Unk)
  • Fludara (25 Mg, Qd)
  • Melphalan
Patient was hospitalized.

Shock, Hypoxia, Pulmonary Oedema, Pyrexia, Lymphocyte Count Decreased, Renal Impairment, Hypotension (7354927-1)
Adverse event was reported on Mar 08, 2011 by a Female taking Prostaglandin E1 (Dosage: 30 Mcg, Unk) was diagnosed with
  • prophylaxis
and. Location: KOREA, REPUBLIC OF , weighting 74.96 lb, Directly after, patient experienced the unwanted or unexpected Prostaglandin side effects: shock, hypoxia, pulmonary oedema, pyrexia, lymphocyte count decreased, renal impairment, hypotension.
Associated medications used:
  • Acetaminophen (Unk)
  • Tylenol (325 Mg, Qd)
  • Thymoglobulin (90 Mg, Qd)
  • Corticosteroids (Unk)
  • Solu-medrol (35 Unk, Unk)
  • Cyclophosphamide (1805 Mg, Qd)
  • Heparin (3600 Iu, Unk)
  • Antihistamines (Unk)


Hypoxia, Renal Impairment, Pyrexia, Hypotension, Pulmonary Oedema, Shock (7280436-4)
on Jan 31, 2011 Female from KOREA, REPUBLIC OF , weighting 74.96 lb, was diagnosed with
  • prophylaxis
and was treated with Prostaglandin E1. Patient felt the following Prostaglandin side effects: hypoxia, renal impairment, pyrexia, hypotension, pulmonary oedema, shock. Prostaglandin E1 dosage: 30 Mcg, Unk.
Multiple prescriptions taken:
  • Thymoglobulin (2.5 Mg/kg, Unk)
  • Thymoglobulin (2.5 Mg/kg, Unk)
  • Heparin (3600 Iu, Unk)
  • Thymoglobulin (2.5 Mg/kg, Unk)
  • Cyclophosphamide (1805 Mg, Qd)


Multi-organ Failure, Pyrexia, Hypoxia, Blood Pressure Decreased, Renal Failure Acute, Cytokine Release Syndrome, Pulmonary Oedema, Shock (7280428-5)
on Jan 31, 2011 Female from KOREA, REPUBLIC OF , weighting 35.27 lb, was diagnosed with
  • prophylaxis
  • bone marrow transplant
  • acute lymphocytic leukaemia recurrent
  • bone marrow conditioning regimen
and was treated with Prostaglandin E1. After Prostaglandin was administered, patient encountered several Prostaglandin side effects: multi-organ failure, pyrexia, hypoxia, blood pressure decreased, renal failure acute, cytokine release syndrome, pulmonary oedema, shock. Prostaglandin E1 dosage: 10 Mcg, Unk.
Multiple concurrent drugs taken:
  • Thymoglobulin (Unk)
  • Melphalan (90 Mg, Qd)
  • Melphalan
  • Fludara (25 Mg, Qd)
  • Fludara
  • Ranitidine (15 Mg, Q12hr)
  • Thymoglobulin (2.5 Mg/kg, Qd)
  • Heparin (1500 Iu, Unk)
Patient was hospitalized.

Cardiac Failure, Collateral Circulation (6857956-7)
Patient was taking Prostaglandin E1 (prostaglandin E1). Directly after, patient experienced the unwanted or unexpected Prostaglandin side effects: cardiac failure, collateral circulation on May 25, 2010 from JAPAN Additional patient health information: Female , weighting 4.41 lb, was diagnosed with
  • hypoplastic left heart syndrome
and. Prostaglandin E1 (prostaglandin E1) dosage: Gradually Increased To 8.0 Ng/kg/min.
Associated medications used:
  • Nitrogen, Liquid


Aorta Hypoplasia, Aortic Stenosis, Cardiac Failure, Cardiac Murmur, Cyanosis Neonatal, Mitral Valve Stenosis, Neonatal Cardiac Failure (6730621-2)
Adverse event was reported on May 05, 2010 by a Female taking Prostaglandin E1 (prostaglandin E1) (Dosage: (gradually Increased To 8.0 Ng/kg/min)) was diagnosed with
  • hypoplastic left heart syndrome
and. Location: JAPAN , weighting 4.41 lb, Patient felt the following Prostaglandin side effects: aorta hypoplasia, aortic stenosis, cardiac failure, cardiac murmur, cyanosis neonatal, mitral valve stenosis, neonatal cardiac failure.
Multiple prescriptions taken:
  • Nitrogen, Liquid


Enterocolitis (6677239-8)
on Mar 26, 2010 Female from FRANCE , weighting 115.0 lb, was diagnosed with
  • heart disease congenital
and was treated with Prostaglandin E1 (prostaglandin E1). After Prostaglandin was administered, patient encountered several Prostaglandin side effects: enterocolitis. Prostaglandin E1 (prostaglandin E1) dosage: (intravenous (not Otherwise Specified) ).

Feeding Disorder Neonatal, Iatrogenic Injury, Neonatal Respiratory Distress Syndrome, Obstruction Gastric, Tachycardia (6660739-4)
on Mar 15, 2010 Female from POLAND , weighting 3.75 lb, was diagnosed with
  • heart disease congenital
and was treated with Prostaglandin E1 (prostaglandin). Directly after, patient experienced the unwanted or unexpected Prostaglandin side effects: feeding disorder neonatal, iatrogenic injury, neonatal respiratory distress syndrome, obstruction gastric, tachycardia. Prostaglandin E1 (prostaglandin) dosage: (started At 0.05ug/kg/min And Reduced To 0.025ug/kg/min).

Diarrhoea Neonatal, Feeding Disorder Neonatal, Pyloric Stenosis, Vomiting Projectile (6660734-5)
Patient was taking Prostaglandin E1 (prostaglandin). Patient felt the following Prostaglandin side effects: diarrhoea neonatal, feeding disorder neonatal, pyloric stenosis, vomiting projectile on Mar 15, 2010 from POLAND Additional patient health information: Female , weighting 7.50 lb, was diagnosed with
  • heart disease congenital
and. Prostaglandin E1 (prostaglandin) dosage: (0.05ug/kg/min).

Cerebral Infarction, Chlamydial Infection, Disseminated Intravascular Coagulation, Finger Amputation, Gangrene, Haemorrhage, Heart Rate Increased, Myocarditis, Respiratory Rate Increased (6426565-6)
Adverse event was reported on Oct 14, 2009 by a Female taking Prostaglandin E1 (Dosage: N/A) was diagnosed with
  • cyanosis
and. Location: CHINA , 43 years of age, After Prostaglandin was administered, patient encountered several Prostaglandin side effects: cerebral infarction, chlamydial infection, disseminated intravascular coagulation, finger amputation, gangrene, haemorrhage, heart rate increased, myocarditis, respiratory rate increased.

Arteriospasm Coronary, Atrioventricular Block, Bradycardia, Cardiac Arrest, Electrocardiogram St Segment Depression, Electrocardiogram St Segment Elevation, Electrocardiogram T Wave Inversion, Hypotension, No Therapeutic Response (6148766-7)
on Mar 19, 2009 Female from JAPAN , 60 years of age, weighting 119.0 lb, was diagnosed with
  • hypotensive anaesthesia procedure
and was treated with Prostaglandin E1 (prostaglandin E1). Directly after, patient experienced the unwanted or unexpected Prostaglandin side effects: arteriospasm coronary, atrioventricular block, bradycardia, cardiac arrest, electrocardiogram st segment depression, electrocardiogram st segment elevation, electrocardiogram t wave inversion, hypotension, no therapeutic response. Prostaglandin E1 (prostaglandin E1) dosage: (0.03 Ug/kg/min Intravenous (not Otherwise Specified).
Associated medications used:
  • Propofol ((intravenous (not Otherwise Specified)), (4 Mg/kg/h Intravenous (not Otherwise Specified))
  • Propranolol ((intravenous (not Otherwise Specified))
  • Fentanyl
  • Vecuronium Bromide
Patient was hospitalized.

Caesarean Section, Foetal Heart Rate Decreased, Hypotonia Neonatal, Neonatal Asphyxia (5663918-8)
on Mar 04, 2008 Female from GERMANY , weighting 8.38 lb, was diagnosed with
  • labour induction
and was treated with Prostaglandin (pge2) (prostaglandin (pge2)). Patient felt the following Prostaglandin side effects: caesarean section, foetal heart rate decreased, hypotonia neonatal, neonatal asphyxia. Prostaglandin (pge2) (prostaglandin (pge2)) dosage: 3 Mg Once Vg.
Multiple prescriptions taken:
  • Oxytocin
Patient was hospitalized.

Caesarean Section, Neonatal Asphyxia (5660310-7)
Patient was taking Prostaglandin. After Prostaglandin was administered, patient encountered several Prostaglandin side effects: caesarean section, neonatal asphyxia on Feb 21, 2008 from GERMANY Additional patient health information: Patient , weighting 8.38 lb, was diagnosed with
  • labour induction
and. Prostaglandin dosage: 3 Mg Once Transplacental.
Multiple concurrent drugs taken:
  • Oxytocin
Patient was hospitalized.

Prostaglandin Health Episodes

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Prostaglandin Information

More About Prostaglandin

Side Effects reported to FDA: 18. View Prostaglandin Adverse Reports

Prostaglandin safety alerts: No

Reported deaths: 2

Reported hospitalizations: 2

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